At Quest Global, it’s not just what we do but how and why we do it that makes us different. With over 25 years as an engineering services provider, we believe in the power of doing things differently to make the impossible possible. Our people are driven by the desire to make the world a better place—to make a positive difference that contributes to a brighter future. We bring together technologies and industries, alongside the contributions of diverse individuals who are empowered by an intentional workplace culture, to solve problems better and faster.
Job Description: Manufacturing Engineer
Location: Chennai Experience: 2 – 5 Years Industry: Medical Devices
Role Overview
As a Manufacturing Engineer, you will provide critical technical support to the Manufacturing Lead and Senior Technical Manufacturing Lead in bridging the gap between product design and large-scale manufacturing. This role focuses on the execution of process development, equipment validation, and production optimization for medical consumables and electromechanical devices.
Key Responsibilities
Process Development & Technical Execution
Assist the Senior Lead in executing Design for Manufacturing (DFM) and Design for Assembly (DFA) reviews to ensure seamless product transitions.
Draft and update comprehensive Standard Operating Procedures (SOPs), manufacturing work instructions, and technical specifications.
Support the production floor by performing Root Cause Analysis (RCA) using tools like 5-Why or Fishbone diagrams to resolve real-time yield issues and line stoppages.
Identify opportunities for process improvements and waste reduction through Lean manufacturing principles.
Validation & Quality Compliance
Draft and execute IQ/OQ/PQ (Installation, Operational, and Performance Qualification) protocols for production equipment and manual/semi-automated assembly lines.
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Participate in PFMEA sessions, taking ownership of technical action items to mitigate identified manufacturing risks.
Conduct Measurement System Analysis (MSA) and Test Method Validations (TMV) to ensure measurement accuracy and repeatability.
Maintain accurate documentation within the Device Master Record (DMR) and Design History File (DHF) in strict accordance with ISO 13485 standards.
Use PLM systems (e.g., Windchill or Teamcenter) for Engineering Change Management and Jira for tracking daily technical tasks and sprint progress.
Coordinate with external vendors for the fabrication of custom jigs, fixtures, and tooling, ensuring they meet technical requirements.
Act as a key liaison between the production team and the Senior Technical Lead to ensure project deadlines are met without compromising quality.
Qualifications & Experience
Education: Bachelor’s degree in mechanical, Manufacturing, or Biomedical Engineering.
Experience: 2–5 years of hands-on experience in manufacturing engineering, ideally within Medical Devices or other highly regulated industries (e.g., Automotive, Aerospace).
- Technical Skills:
Foundational knowledge of ISO 13485 and FDA 21 CFR Part 820.
Proficiency in 2D/3D CAD software (SolidWorks or AutoCAD).
Experience with statistical tools (Minitab) and Lean Six Sigma methodologies.
Experience in Medical Device Consumables or cleanroom manufacturing is a significant advantage.
Work Experience
Qualifications & Experience
Education: Bachelor’s degree in mechanical, Manufacturing, or Biomedical Engineering.
Experience: 2–5 years of hands-on experience in manufacturing engineering, ideally within Medical Devices or other highly regulated industries (e.g., Automotive, Aerospace).
- Technical Skills:
Foundational knowledge of ISO 13485 and FDA 21 CFR Part 820.
Proficiency in 2D/3D CAD software (SolidWorks or AutoCAD).
Experience with statistical tools (Minitab) and Lean Six Sigma methodologies.
Experience in Medical Device Consumables or cleanroom manufacturing is a significant advantage.
Benefits
As per Quest company policy
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